It has been a year since the South African and Indian delegations to the World Trade Organization tabled their proposal to temporarily waive intellectual property protections governing COVID-19 vaccines, diagnostics, and therapeutics. The waiver was needed because of the lack of “meaningful global policy
solutions to ensure access” to those products, particularly for the world’s poorest, the South African delegation argued A year later, about 77% of the 6.41 billion vaccine doses so far administered globally have gone to people in high- and upper-middle-income countries. But the proposal remains stalled, despite the support of more than 100 countries.
It is impossible to determine how many lives, if any, would have been saved by the quick adoption of India and South Africa’s proposal. Interviews with scientists, activists, legal scholars, regulatory experts, and manufacturing authorities revealed a striking lack of consensus on the actual effect its approval would have had.
At the very least, “if we had taken that step a year ago and started that process a year ago, a lot of countries would be in a better spot. We would be facing a different global landscape,” said Rachel Thrasher, a researcher at Boston University’s Global Development Policy Center.
‘It’s a question of speed’ In their proposal, South Africa and India are asking to waive the IP protections — including patents, industrial designs, copyrights, and undisclosed information — guarded by the WTO’s agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, for at least three years.
Within the consensus-driven WTO, European opposition arising from concerns about the impact on pharmaceutical innovation has been enough to block the waiver’s adoption. The United States voiced support for a narrow version of the TRIPS waiver in May but has since done little to advance it. The debate is set to resume at the next TRIPS Council meeting this month.
From his vantage point as executive director of the African Vaccine Manufacturing Initiative, Patrick Tippoo, sees myriad challenges to vaccine production that outstrip that debate. There are shortfalls in infrastructure and supply chains, as well as the experts needed to make both work. Key regulatory agencies are missing. Then there is an even bigger deficiency on a continent where most vaccines are provided by UNICEF with the support of Gavi, the Vaccine Alliance.
“There was no market incentive to create an industry and therefore we have ended up in this position,” he said. A position of lack of control over productive capacity amid rampant vaccine nationalism, resulting in only nine African countries hitting a World Health Organization benchmark to vaccinate 10% of their populations by the end of September. “Now we understand that the price we have to pay to install vaccine production capacity is far smaller than the price we are paying now,” Tippoo said.
“If we had taken that step a year ago and started that process a year ago, a lot of countries would be in a better spot.” — Rachel Thrasher, researcher, Boston University’s Global Development Policy Center
He acknowledges the TRIPS waiver, which promises access to patents and other knowledge without the risk of challenges from the IP holders, could ultimately benefit the industry. But not until there is what he calls the “absorptive capacity” — including the facilities, engineers, and regulators — to transform that knowledge and technology into vaccines.
Leena Menghaney sees no reason to wait. “Right now, it’s not a question of capacity, it’s a question of speed,” said Menghaney, who is the South Asia head of the Médecins Sans Frontières’ Access Campaign. “It’s a waiver of intellectual property. It’s any kind of action you can take to address the pandemic.”
That includes expediting temporary workarounds to safely bring some facilities to the point where they would have that absorptive capacity.
In a best-case scenario, countries would quickly adopt the domestic legislation allowing them to leverage the flexibilities afforded by the TRIPS waiver, even as governments sourced the funds needed to acquire supplies and retrofit existing facilities.
There is no shortage of potential candidates, including plants that have already acquired time-intensive regulatory approvals. Meanwhile, countries that lack the necessary workforce might turn to a retired corps of engineers from elsewhere in the world until their own staff could be trained.
The advent of the messenger RNA-based vaccines created by Pfizer and Moderna offers an additional advantage: The development process is much faster than that for conventional vaccines. With the facilities in place, the actual production process for an mRNA vaccine could begin within three or four months, said Suhaib Siddiqi, the former director of chemistry at Moderna.
“It’s not that difficult if the facilities are there,” he said. MSF modeled a scenario where within 10 months facilities currently producing injectable medicines could, with an infusion of at least $127 million and some expansion, be in a position to produce up to 100 million mRNA vaccine doses annually.
These timelines are contingent on the participation of vaccine developers in transferring vital technology. The TRIPS waiver would essentially facilitate access to a vaccine blueprint, but it does not spell out how to compel companies to fully collaborate in the tech transfers. These potentially monthlong processes are necessary to explain how to actually construct the vaccines.
Without the transfers, new manufacturers could end up spending a “year or two reinventing the wheel,” Siddiqi said. If the cost does not deter them, the regulatory implications might.
If the originating company designates a facility as a secondary manufacturing site and can demonstrate that the product made there is identical to the original, then the new facility can avoid the length and expense of clinical trials, said Prashant Yadav, a supply chain expert at the Center for Global Development.
Without that designation, any eventual vaccine is considered a new product, he said, even if the process and manufacturing information for producing it are derived from the originating company — accessed via the TRIPS waiver, for instance. That would necessitate clinical trials and other regulatory hurdles.
Even as they distribute voluntary licenses to hand-selected sites, there has been no indication from Pfizer, BioNTech, or Moderna that they would willingly participate in technology transfers or enter into partnerships with facilities that leverage the TRIPS waiver to acquire IP.
For Yadav, the solution is clear: “The fastest pathway is voluntary licensing or building secondary sites,” he said. Waiver advocates reject that determination, arguing that by allowing the companies to continue to set the terms of their engagement, it perpetuates an IP regime that prioritizes profits over access.
“The current system basically works in favor of a few rich countries, rich people in middle-income and poor countries,” MSF’s Menghaney said. “IP is a large part of the control that rich countries have had.”
She positions the TRIPS waiver not as a singular initiative, but within a broader continuum of efforts to reconsider IP driven by the urgency of delivering medical products in a pandemic. That continuum may include additional strategies to compel companies to participate in technology transfers.
Thrasher laid out several possibilities, emphasizing that “to get the cooperation from these companies, it has to be a combination of carrots and sticks.”
Under current laws, the U.S. government could essentially expropriate the information and then compensate the companies. Experts have also begun to look within the TRIPS agreement, itself, for cover to justify involuntary technology transfers. Governments seeking cooperation could also lard on incentives, including tax breaks, to bring companies on board. But Thrasher also cautioned, “These are going to be complicated policy decisions.”
What is at stake Within this landscape of potential interventions, it is possible to sketch out a scenario where quick approval of the TRIPS waiver could have escalated vaccine production. It is a debate that opponents of the waiver hope will be overtaken as increased production appears set to eventually smooth out current disparities, at least in vaccine access.
Waiver proponents refuse to relent, not least because there is no guarantee that the production surpluses will automatically translate into improved access. So long as a handful of countries retain control over manufacturing, they can restrict supply, as India demonstrated when its government cut off exports in May to grapple with its own outbreak. There are also worries that richer countries will continue to gobble up supply as they approve booster shots. Even if it does result in immediate expansion of approved vaccines, the waiver could ease the development of new products. Yadav said it could help protect those efforts from being “undermined because they get stuck by an IP roadblock,” such as finding that a small component of their vaccine has a patent protection.
Vaccine access is not all that is at stake. The waiver also covers diagnostics and therapeutics, including Merck’s promising antiviral and similar advances, which could soon be central to efforts to combat the virus.
“Low- and middle-income countries need them more than anybody else,” said Esteban Burrone, the head of policy at the Medicines Patent Pool. “They have more people at risk because there’s so much less vaccination happening now.”
The process of manufacturing those treatments is less complicated than for vaccines and more broadly established. That means an IP waiver, even without technology transfers, could speed their production and availability. Alongside its immediate implications, the waiver is also a provocation, or a “wedge issue,” as Menghaney described it, designed to force a reckoning with the current IP regime.
The global south can take the steps to address the other deficiencies that limit its absorptive capacity — and already are. For instance, African leaders committed to improving vaccine manufacturing on the continent. And development is underway for a WHO-backed tech transfer hub in South Africa that could eventually offer the kind of know-how that BioNTech, Pfizer, and Moderna seem unwilling to provide.
But waiver proponents also want to force a discussion about how IP protections helped to shape and perpetuate those deficiencies and to consider how a change in those protections could also help redress the imbalances. A TRIPS waiver remains their starting point.
“When the next pandemic hits, the supply and scaling up can take place and we don’t have to talk about waivers,” Tahir Amin, the co-founder of the Initiative for Medicines, Access & Knowledge said during last month’s WTO Public Forum. “This is the first step in that direction.”
Disclaimer: This news story has been edited by DNW staff as per DNW editorial guidelines and is published from a syndicated feed. Source: Andrew Green, Image : Public domain.
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